California Proposition 65 & State Regulations

Haley Will and Jennifer Buoniconti

UL / PPAI Product Safety Consultants

This information is being furnished by PPAI for educational

and informational purposes only. The Association makes no

warranties or representations about specific dates,

coverage or application. Consult with appropriate legal

counsel about the specific application of the law to your

business and products.

Preemption (CPSIA, Section 231)

• If covered by a Federal regulation (CPSA, FHSA, FFA,

PPPA), the State or Local law is essentially preempted

• Preemption does not apply for California Proposition 65

• Preemption does not apply to restrictions not covered by

Federal regulation

• State may apply for exemption from preemption

• The Safe Drinking Water and Toxic Enforcement

Act of 1986

• Administered by the Office of Environmental Health

Hazard Assessment (OEHHA)

California Proposition 65

California Proposition 65 Overview

• State must publish a list of chemicals known to cause

cancer, birth defects or other reproductive harm

• Business are required to provide a “clear and

reasonable” warning before knowingly and intentionally

exposing anyone to a listed chemical

• Allows Californians to make “informed decisions” about

protecting themselves from exposure to these

chemicals

California Proposition 65 Exposure

• “Exposure” regulation

• Methods of exposure can be oral, inhalation,

transdermal, hand-to-mouth

• Measured in micrograms per day, based on average

use of the product

• Most recent cases involving lead and phthalates reflect

CPSIA allowable limits

California Proposition 65 Requirements for Businesses

• Provide clear and reasonable

warning before knowingly or

intentionally exposing anyone to a listed chemical

• Once a chemical is listed, companies have 12 months

to comply with warning requirements

• Companies can comply if chemicals are within “safe

harbor” limits

California Proposition 65 Exemptions

• Businesses with less than 10 employees

• Governmental agencies and public water systems

• Safe harbor levels have been established for many

Prop 65 listed chemicals.

• Exempt if No Significant Risk Level (NSRLs) for

cancer-causing chemicals and Maximum Allowable

Dose Levels (MADLs) for chemicals causing

reproductive toxicity are not exceeded.

California Proposition 65 Enforcement

• Enforced by State Attorney General’s Office as well

as District Attorneys and City Attorneys

• Private Enforcers – any individual acting in the

public’s interest may enforce by filing a lawsuit

(majority of claims)

• Penalties up to $2,500 per violation, per day

California Proposition 65 Frequently Targeted Products

Jewelry for adults and

children (lead and

cadmium)

Decorated glass

and ceramic

drinkware (lead and

cadmium)

Padfolios, desk

accessories,

checkbook covers,

phone covers,

luggage tags (lead

and phthalates)

Leather goods,

belts, wallets,

footwear,

eyeglass cases

(lead)

California Proposition 65 Frequently Targeted Products

Sporting goods and

children’s toys (lead

and phthalates)

Electronics and

electrical cords (lead,

cadmium, phthalates)

Tableware, picnic

products, distilled

spirits, wine, beer

(lead, phthalates,

sulfites)

Plastic items,

especially those

made with PVC

(phthalates)

California Proposition 65 How to Comply

Review the list of chemicals published and updated by the Office of

Environmental Health and Hazard Assessment (OEHHA) found at

www.oehha.ca.gov

Confirm with your suppliers or manufacturer that none of the

chemicals have been intentionally added to your product

Ask your customer if product will be distributed in California

Ask for test reports

Test and comply with CA Prop 65 settlements

Test for usual suspects (lead, cadmium, phthalates)

Apply warning labels if your product contains any of the listed

chemicals

Other US State Regulations

• Northeast Recycling Council (NERC)

• Illinois Lead Poisoning Prevention Act

• Washington State Children’s Safe Product Act

• Bisphenol A (BPA)

• Other State Legislations

NERC Toxins in Packaging Overview

• Developed in 1989 to reduce the amount of four heavy metals in

packaging components distributed in the United States

• Has been adopted by nineteen states

• The sum of the concentrated levels of incidentally added Lead,

Mercury, Cadmium and Hexavalent Chromium present in any

packaging component cannot exceed 100 ppm

NERC Toxins in Packaging What are packaging materials?

• Master shipping cartons

• Individual product packaging (gift box, plastic bag, header

card, blister pack etc.)

• Components used on shipping cartons (glue, tape, inks,

staples, stickers etc.)

NERC Toxins in Packaging Who is responsible?

• Manufacturers of packaging and packaging components

• Suppliers of packaging and packaging components

• Product manufacturers or distributors who use packaging

Illinois Lead Poisoning Prevention Act Overview

Effective January 1, 2010

Warning labels are required for certain products:

• Toys, child care articles (up to 6 years) and children’s jewelry

(up to 12 years) if lead in surface coating is >40 ppm

• Child care articles and children’s jewelry if lead in substrate is

>40 ppm

• Adult items if lead in surface coating or substrate is >600 ppm

Illinois Lead Poisoning Prevention Act Warning Statement

• The warning statement must appear on the product itself or

the product’s immediate container and must include the

following wording:

“WARNING: CONTAINS LEAD. MAY BE HARMFUL IF EATEN

OR CHEWED. MAY GENERATE DUST CONTAINING LEAD”

• Identification of chemicals with potential adverse effects

on children

(focus on the highest priority chemicals)

• Requires manufacturers of children’s products to notify

the Department of Ecology when “Chemicals of High

Concern to Children” (CHCC) are present in the product

• Sixty-six (66) chemicals are currently identified as

CHCC’s

Washington State

Children’s Safe Products Act Overview

Reporting is based on two factors:

1. Size of the manufacturer

2. Tier of children’s product

Washington State

Children’s Safe Products Act Reporting

Washington State

Children’s Safe Products Act Reporting Schedule

Manufacturer Categories Product Tier 1 Product Tier 2 Product Tier 3 Product Tier 4

Largest

Annual sales > $1 Billion

8/31/12 2/28/13 8/31/13 case-by-case

Larger

Annual sales $250M to <$1B

2/28/13 8/31/13 8/31/14 case-by-case

Medium

Annual sales $100M to

<$250M

8/31/13 8/31/14 8/31/15 case-by-case

Small

Annual sales $5M to <$100M

8/31/14 8/31/15 8/31/16 case-by-case

Smaller

Annual sales $100K to <$5M

8/31/15 8/31/16 8/31/17 case-by-case

Tiny

Annual sales< $100K

8/31/16 8/31/17 8/31/18 case-by-case

• Test for all 66 chemicals in all materials

– Costly

– Unnecessary

• Research-based approach

– Identify where chemicals may be found

– Classify whether chemical is intentionally added, contaminant or

not used

– Perform reduced testing, as needed, to determine reporting

obligation

Washington State

Children’s Safe Products Act Best Practices

• Primarily used in polycarbonate plastic as well as epoxy

resins and polysulfone materials

• Used in baby bottles and water bottles for decades

• Also used in coatings on the inside of almost all food and

beverage cans

• FDA ban on use of PC in infant bottles/spill proof cups

Bisphenol A (BPA) Overview

Wisconsin

• BPA banned in baby bottles and sippy cups (<3 years)

• Children’s items must be labeled “BPA-Free”

• BPA also banned in10 other states, mostly in baby bottles

and sippy cups (no labeling required)

CA, CT, DE, ME, MD, MA, MN, NY, WA, and VT

• Legislation pending in other states

Bisphenol A (BPA) Current Legislation

In August 2013, the California Dept. of Toxic Substances Control

Approved the “Safer Consumer Product Regulation”

• Intended to protect public health and environment

• Effective October, 2013

• Establishes a process to identify consumer products and chemicals of

concern

• Approximately 1200 chemicals in total may be identified, 164 initial

candidate chemicals

Additional California Legislation

The DTSC will:

• Designate up to 5 priority products and chemicals for assessment of

safer alternatives (by April 2014)

• Will require Alternatives Assessments for Priority Products/Chemical

combinations

• Will impose conditions for compliance (i.e., warnings, notices,

restrictions or bans on use of chemicals or products

Additional California Legislation

• Maine: Toxic Chemicals in Children’s Products identifies 49

chemicals that are reproductive or developmental toxicants,

endocrine disruptors or carcinogens

• Connecticut, Florida, North Carolina, Oregon, New York…

States with bans on certain flame retardants:

• TRIS, TDCPP, TDCP, TCEP,TCPP, PBDEs, decaBDE, and others

• Found mainly in children’s clothing and furniture due to potential

cancer risk through skin absorption or mouthing

• Connecticut, Delaware, Illinois, Massachusetts, Maryland, Maine,

Missouri, North Carolina, New Jersey, New York, Oregon, Vermont,

Washington…

Other States Regulating

Chemicals of Concern

Plastic Bag Suffocation Warning

Labeling and warning requirements for certain plastic bags

California, Massachusetts, New York, Rhode Island and Virginia

"WARNING: To avoid danger of suffocation,

keep this plastic bag away from babies and children.

Do not use this bag in cribs, beds, carriages or play pens.

This bag is not a toy."

Stuffed Toy Labeling

• Massachusetts, Ohio, Pennsylvania

• Stuffed toys and dolls for the states of PA, MA and OH must conform

with the stuffed toy licensing and labeling laws

• Manufacturers must register and pay fees must be paid to each

state

Stuffed Toy Labeling

• Manufacturers must submit detailed information about the filler

content of the toy

• Specimens of each toy selected at random

• Uniform sewn in label to comply with all three states must contain:

- PA license number of manufacturer or vendor

- Name and principal place of business of the manufacturer or

vendor

- Statement that “all new materials” (with type of material)

Rhode Island Jewelry Legislation

• First state to adopt ASTM F2923-11 as mandatory

• Children’s jewelry manufactured after December 18, 2012 must

conform to the requirements of ASTM standard F2923-11,

Specification for Consumer Product Safety for Children’s Jewelry

Restriction of Hazardous Substances

• California, Minnesota and New Jersey have adopted RoHS

requirements for Electronic Devices

• EN 1122 and EN 62321 method

Drawstrings

• CPSC Final Rule on Drawstrings and Ties took effect on August 18,

2011

• Final Rule is codified in 16 CFR 1120 but does not pre-empt state

requirements for drawstrings

• Additional requirements in New York and Wisconsin

State Requirements –

Hood and Neck Drawstring and Ties

New York Law Wisconsin Law 16 CFR 1120

Type of Apparel All children’s

clothing

All children’s

clothing

Upper outerwear

Sizes 2T-12 0-16 2T-12

Requirements No hood or neck

drawstrings

allowed

No hood or neck

drawstrings

allowed

Drawstrings and

ties cannot be

used in the head

or neck area

State Requirements – Waist of Upper and Lower Clothing

Drawstring

New York Law Wisconsin Law 16 CFR 1120

Type of

Apparel

Children’s upper and

lower clothing

Children’s upper outerwear Children’s upper outerwear

Sizes 2T-16 0-16 2T-16

Requirements - No toggles, knots or

other attachments

- The drawstring

must be attached to

the garment’s

midpoint

- 3 inch rule

- No toggles, knots or

other attachments

- The drawstring must be

sewn at the midpoint of

the channel, so it

cannot be pulled out of

the channel

- 3 inch rule

- No toggles, knots or

other attachments

- The drawstring must be

sewn at the midpoint of

the channel, so it cannot

be pulled out of the

channel

- 3 inch rule

• PPAI: www.ppai.org

• Product Safety powered by PPAI:

http://www.ppai.org/inside-ppai/product-safety/

https://www.ppai.org/inside-ppai/ppai-code-of-conduct/

• Consumer Product Safety Commission: www.cpsc.gov ;

www.recalls.gov

• American National Standards Institute: www.ansi.org or

www.astm.org

• UL: www.UL.com or Haley.Will@ul.com

• Questions? AnneL@ppai.org

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